{"url_path":"/fda/device/recalls/Z-2793-2026","section_key":"summary","section_title":"DEVICE Recall: Alphatec Spine, Inc. — SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-13","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2793-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Alphatec Spine, Inc."},"word_count":117,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2793-2026\n\n**Recalling firm:** Alphatec Spine, Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-13\n**Report date:** 2026-07-29\n\n## Product\nSafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System\n\n## Reason\nIntraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring system reboot; may result in increased operative time and surgical plan change.\n\n## Affected lots\nUDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230\n\n## Distribution\nUS Nationwide distribution in the states of TX, MO, IN."}